BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-TAPER LINER SZ 41/32

    MDR report key: 7476114 · Received May 1, 2018

    Report

    Report Number
    0001825034-2017-09841
    Event Type
    Injury
    Date Received
    May 1, 2018
    Report Date
    May 1, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-163669, 32MM M2A MOD HEAD STD NK, 523970, 13-103209, TAPERLOC POR RED/LAT 17.5X155, 085710, 15-103688, M2A-T UNIV 2-HOLE SHL SZ 41/58, 780070, 13-103209, TAPERLOC POR RED/LAT 17.5X155, 085710, 103537, TI LOW PROFILE SCREW 6.5X50MM, 980780. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED OP NOTES. REVISION OP NOTES INDICATE PATIENT HAVING DRAINAGE THROUGH HIS HIP SURGICAL INCISION SITE. PATIENT HAVING HIP PROBLEMS AND INCREASED PAIN BEFORE REVISION. IT WAS EVALUATED AND FOUND OUT TO BE MRSA. IT WAS NOTED THAT PATIENT'S COBALT LEVEL WAS ELEVATED BUT THE CHROMIM WAS NOT. SURGEON NOTED BLACK MATERIAL ALONG THE TRUNNION CONSISTENT WITH METAL CORROSION. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 09843, 0001825034 - 2017 - 09844.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO INFECTION GREATER THAN ONE YEAR POST-OPERATIVELY, ELEVATED COBALT ION LEVELS, AND METALLOSIS. FLUID ASPIRATION WAS PERFORMED PRIOR TO THE PROCEDURE. IT WAS NOTED THAT THERE WAS YELLOW FLUID WITH SOME CLOUDY CONSISTENCY. THERE WAS ALSO BLACK MATERIAL IN THE TRUNNION THAT WAS CONSISTENT WITH METAL CORROSION. ALL PRODUCTS WERE REMOVED AND REPLACED WITH CEMENT SPACER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320479 M2A-TAPER LINER SZ 41/32 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 552400

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R